液相色谱-质谱联用法测定佐米曲普坦血药浓度及生物等效性研究

HPLC-MS determination of zolmitriptan in human plasma and research of its bioequivalence

目的:建立测定健康受试者血浆样品中佐米曲普坦浓度的液相色谱-质谱(HPLC-MS)定量分析方法。方法:血浆样品经乙腈直接沉淀并在真空泵中挥干后,利用 HPLC-MS/MS 选择性离子检测。结果:本法线性范围为0.1～40ng·mL^(-1),最小检出浓度为0.05 ng·mL^(-1),日内、日间 RSD 均小于15%。结论:本法可以用于测定血浆中佐米曲普坦浓度,方法准确、灵敏、快速,重现性好。

Objective：To establish an HPLC - MS method for determination of zolmitriptan in human plasma. Methods：The plasma sample was deproteinated by acetonitrile, and after it was dried by the vacuum pump, the sample was injected into the HPLC - MS/MS system. Result： The linear range of zolmitriptan was 0. 1 - 40 ng ·mL^-1, and the detection limit was 0.05 ng ·mL^-1. The intra and inter day RSD of zolmitriptan were all less than 15%. Conclusion：The assay method is shown to be suitable for determining the concentration of zolmitriptan in plasma. This method is accurate, sensitive, rapid and reproducible.